Cytotoxic T Cells and Interleukin-2 in Treating Adult Patients With Recurrent Brain Tumors
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|ClinicalTrials.gov Identifier: NCT00002572|
Recruitment Status : Completed
First Posted : July 29, 2004
Last Update Posted : May 30, 2013
RATIONALE: Biological therapy uses different ways to stimulate the immune system and stop cancer cells from growing. Cytotoxic T cells combined with interleukin-2 may be an effective treatment for recurrent brain tumors.
PURPOSE: Phase I trial to study the effectiveness of cytotoxic T cells and interleukin-2 in treating adults with recurrent brain tumors.
|Condition or disease||Intervention/treatment||Phase|
|Brain and Central Nervous System Tumors||Biological: aldesleukin Biological: muromonab-CD3 Biological: therapeutic tumor infiltrating lymphocytes Procedure: conventional surgery||Phase 1|
OBJECTIVES: I. Evaluate the toxicity of allogeneic cytotoxic T lymphocytes (CTL) when repeatedly instilled directly into the brain to treat recurrent primary brain tumors. II. Evaluate the response produced by allogeneic CTL and interleukin-2. III. Correlate CTL surface phenotype and degree of patient/donor HLA mismatch to response and toxicity.
OUTLINE: Surgery plus Biological Response Modifier Therapy. Tumor resection; plus intracavitary cytotoxic T lymphocytes, CTL; intracavitary Interleukin-2 (Chiron), IL-2, NSC-373364. CTL are generated in vitro by mixing irradiated patient lymphocytes (cultured with IL-2 and Monoclonal Antibody OKT 3, MOAB OKT 3, NSC-618843) with allogeneic lymphocytes and culturing the mixture with IL-2.
PROJECTED ACCRUAL: 10 patients will be treated. If severe toxicity occurs in the first 5 patients, the study will close.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Official Title:||Intracavitary Allogenic Cytotoxic T Lymphocytes and Human Recombinant Interleukin-2 Therapy for Recurrent Primary Brain Tumors|
|Study Start Date :||November 1994|
|Actual Primary Completion Date :||December 1999|
|Actual Study Completion Date :||December 1999|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002572
|United States, Colorado|
|Children's Health Center|
|Denver, Colorado, United States, 80218|
|Veterans Affairs Medical Center - Denver|
|Denver, Colorado, United States, 80220|
|University of Colorado Cancer Center|
|Denver, Colorado, United States, 80262|
|Study Chair:||Kevin O. Lillehei, MD||University of Colorado, Denver|